Physical Therapy Prior to Total Knee Replacement | NCT02279277

Studies
Physical Therapy Prior to Total Knee Replacement

NCT02279277

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Oct 31, 2014Estimated

Enrollment

148Estimated

Phase

Not Applicable

Conditions

Osteoarthritis of the Hip

Interventions

Supervised physical therapy program prior to total knee replacement surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Oct 28, 2014

First Posted Date

Oct 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2014

Last Update Posted Date

Oct 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No physical therapy	No Intervention	No prescribed, supervised physical therapy prior to total knee replacement
Physical Therapy	Active Comparator	Prescribed, supervised physical therapy prior to total knee replacement	Behavioral: Supervised physical therapy program prior to total knee replacement surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supervised physical therapy program prior to total knee replacement surgery	Behavioral		Physical Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of Motion following Total Knee Replacement		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient reported perception of pain following total knee replacement		6 weeks
Return to functional activities following total knee replacement		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

Anyone who received physical therapy in the last 6 months
Inability to walk unaided for >1 block
Currently engaged in regular PT or a regular home exercise program
Prior knee arthroplasty
Prior knee surgery for trauma, tumor and osteotomy
Injection given within 6 weeks of starting therapy
Patients using daily narcotic medications within prior 6 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided